Cleared Traditional

K180590 - Tyber Medical PT Interbody Spacer System

K180590 is the FDA 510(k) clearance for Tyber Medical PT Interbody Spacer System by Tyber Medical, LLC. It is a Class 2 Orthopedic device (product code ODP) cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K180590 · Tyber Medical, LLC · Orthopedic device
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Jul 2018
Decision
122d
Days
Class 2
Risk

K180590 is an FDA 510(k) clearance for the Tyber Medical PT Interbody Spacer System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Tyber Medical, LLC (Bethlehem, US). The FDA issued a Cleared decision on July 6, 2018 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Tyber Medical, LLC devices

Submission Details

510(k) Number K180590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2018
Decision Date July 06, 2018
Days to Decision 122 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 122d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ODP Intervertebral Fusion Device With Bone Graft, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 219
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K180590.
ATEC Cervical Spacer System
K181435 · Alphatec Spine, Inc. · Aug 2018
CxHA PEEK Cervical IBF System
K181115 · Innovasis, Inc. · Jul 2018
Curiteva Cervical Interbody Fusion System
K181261 · Curiteva, LLC · Jul 2018
HD LifeSciences Cervical IBFD System
K180364 · Hd Lifesciences, LLC · Jun 2018
MONET™ Anterior Cervical Interbody Fusion Cage System
K172788 · Ctl Medical Corporation · Jun 2018
EVOL® ha-C Cervical Interbody Fusion System
K180674 · Cutting Edge Spine, LLC · Jun 2018